Category Archives: Immunology

Immunology

AnPac Bio Sets Record Test Volume in Q3, and Forecasts ~ 100% Revenue Growth in 2020 – BioSpace

SAN JOSE, Calif., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Anpac Bio-Medical Science Co., Ltd. (AnPac Bio, the Company or we) (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, announced today that it experienced strong demand for its cancer screening tests and set a record in paid test volume in the third quarter. With a strong fourth quarter already underway, the Company forecasts a revenue growth of approximately 100% in 2020 over 2019, with a revenue range of US$3 million (~ RMB20 million) to US$3.3 million (~ RMB22 million). For 2019, the Company had a revenue of US$1.6 million (~ RMB10.9 million) (using a current US$ to RMB exchange ratio of ~ 6.6). We expect the strong momentum of YoY revenue growth due to market demand and customers accepting AnPac Bios novel cancer screening technology with multiple advantages (named cancer differentiation analysis (CDA) technology)) to continue into 2021. The Company plans to release its full year 2020 audited financial report in early March 2021.

With COVID-19 mainly contained in China and most businesses returning to normal operations since May, the demand for the Companys cancer screening tests has remained strong. Further, its average selling price (ASP) in 2020 is expected to increase compared to 2019, contributing to a higher revenue growth forecast. In 2020, the Company has launched a number of new products including an immunology test in China and the COVID-19 antibody test in the US.

Dr. Chris Yu commented, Our strong paid test volume in the third quarter demonstrated our novel, biophysics based CDA technology and its advantages in cost effectiveness, the ability to detect early a wide range of cancer types (over 20 cancer types), and relatively high sensitivity and specificity are increasingly being accepted and recognized by the market and customers. With our successful IPO on the NASDAQ earlier this year, we are now focusing on three areas: new product development, product commercialization including in the US, and revenue growth through sales, with an emphasis on execution and speed. Having successfully executed our phase one goal to become a volume leader in cancer screening among new generation cancer screening technologies, we are now turning our attention to enhance our ASP and gross margin. We have recorded an increase in ASP and launched two new products, which paved the way for further business growth. We are optimistic about our Company including commercialization in the US and growth in 2021.

About AnPac Bio

AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory and one CLIA registered clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), bio-chemical, immunological, and genomics tests. According to Frost & Sullivan, AnPac Bio ranked third worldwide and first in China among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection, based on approximately 41,700 clinical samples as at May 2020. AnPac Bios CDA technology platform has been shown in retrospective validation studies to be able to detect the risk of over 20 different cancer types with high sensitivity and specificity.

For more information, please visit: https://www.Anpacbio.com.

For investor and media inquiries, please contact:

Company:Phil Case, Marketing and Investor RelationsPhone: +1-267-810-6776 (US)Email:phil_case@AnPacbio.com

Investor Relations:Ascent Investor Relations LLCTina Xiao, PresidentPhone: +1-917-609-0333 (US)Email:tina.xiao@ascent-ir.com

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. The Company has attempted to identify forward-looking statements by terminologies including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," target, aim, predict, outlook, seek, goal objective, assume, contemplate, continue, positioned, forecast, likely, "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the implementation of our business model and growth strategies; trends and competition in the cancer screening and detection market; our expectations regarding demand for and market acceptance of our cancer screening and detection tests and our ability to expand our customer base; our ability to obtain and maintain intellectual property protections for our CDA technology and our continued research and development to keep pace with technology developments; our ability to obtain and maintain regulatory approvals from the NMPA, the FDA and the relevant U.S. states and have our laboratories certified or accredited by authorities including the CLIA; our future business development, financial condition and results of operations and our ability to obtain financing cost-effectively; potential changes of government regulations; general economic and business conditions in China and elsewhere; our ability to hire and maintain key personnel; our relationship with our major business partners and customers; and the duration of the coronavirus outbreaks and their potential adverse impact on the economic conditions and financial markets and our business and financial performance, such as resulting from reduced commercial activities due to quarantines and travel restrictions instituted by China, the U.S. and many other countries around the world to contain the spread of the virus. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Company's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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AnPac Bio Sets Record Test Volume in Q3, and Forecasts ~ 100% Revenue Growth in 2020 - BioSpace

Immunology

Genetic modification in coat of fatal brain virus may allow it to escape antibodies – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Nov 20 2020

A genetic modification in the 'coat' of a brain infection-causing virus may allow it to escape antibodies, according to Penn State College of Medicine researchers. They say testing people for this and other viral mutations may help identify patients at risk for developing a fatal brain disease.

Dr. Aron Lukacher, professor and chair of the Department of Microbiology and Immunology at the College of Medicine, and Susan Hafenstein, professor of medicine and microbiology and immunology at the College of Medicine and professor of biochemistry and molecular biology at Penn State Eberly College of Science, co-led a research team that used high-resolution microscopy to study the capsid or outer shell of mouse polyomavirus (MuPyV).

This virus is a genetic model of JC polyomavirus (JCPyV), which is present and harmless in most people and can cause progressive multifocal leukoencephalopathy (PML), a brain disease, in people taking immunosuppressive therapies.

Genetic mutations in the capsid of JCPyV are common in PML patients and scientists to have struggled to understand whether they allow the virus to infect brain cells or whether the resulting changes allow the virus to evade elimination by antiviral antibodies and then cause brain infection.

Lukacher and Hafenstein studied the mouse equivalent of a common genetic mutation in JC polyomavirus to try and better understand how it may cause PML.

"Not much is known about how this particular genetic mutation in the JC polyomavirus capsid leads to PML," Lukacher said. "It has been detected in the blood, cerebrospinal fluid and brain tissues of PML patients but not in their urine. This unmutated virus typically sits dormant in the kidneys of healthy people, which got us wondering how this particular mutation contributes to disease progression."

The researchers introduced a genetic mutation in the MuPyV capsid similar to one found in JCPyV and conducted a series of experiments to compare outcomes between MuPyV and the altered virus. The virus mutates by swapping out one amino acid, the chemical ingredients used to build the capsid, for another. They found the virus was still able to cause central nervous system infection and hydrocephalus, or brain swelling.

To study how the mutation allows the virus to evade antibodies, the research team, including doctoral student Matthew Lauver and medical scientist training program student Daniel Goetschius, used cryogenic electron microscopy to determine the 3D, atomic-resolution structure of the virus particles bound to monoclonal antibodies. The results of their analyses were published in the journal eLife.

The team examined the structural features to see how the monoclonal antibodies recognize the virus capsid and neutralize it. They found that the capsid mutation prevents the monoclonal antibody from being able to interact with the virus, increasing the chances that the virus can infect the brain when patients become immune-suppressed.

We studied how other mutations affected MuPyV and found many of them result in impaired kidney and retained brain viral infection. However, only a few of these result in the ability of the virus to evade the immune response."

Dr. Aron Lukacher, Researcher, Professor and Chair, Department of Microbiology and Immunology, College of Medicine, Penn State Cancer Institute

According to Lukacher, more research is needed to determine which JCPyV mutations cause the virus to evade antibodies. He said the goal would be to develop screenings for patients with multiple sclerosis receiving immune-modulating therapies, as well as those immune-compromised by cancers and AIDS, to see who might be at increased risk for developing PML.

Source:

Journal reference:

Lauver, M. D., et al. (2020) Antibody escape by polyomavirus capsid mutation facilitates neurovirulence. eLife. doi.org/10.7554/eLife.61056.

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Genetic modification in coat of fatal brain virus may allow it to escape antibodies - News-Medical.Net

Immunology

Improving Patient & Family Knowledge of Oral Immunotherapy – Physician’s Weekly

My colleagues and I believe that oral immunotherapy (OIT) is a massive shift for families in the management of food allergy, states Douglas P, Mack, MD. Essentially, allergists and immunologists have moved from telling families to avoid foods to which their children are allergic to telling them it is safe to slowly introduce these food under our guidance, resulting in them having to function like junior medical professionals and to be able to manage the decision about whether or not their child is well enough to take an immunotherapy dose at home and any potential reactions that can occur.

Dr. Mack adds that in the early stages of OIT implementation, families were not well prepared, in his opinion, and their expectations did not align with the reality of the challenges of the OIT process. With the shift in responsibility for families that comes with OIT, shared decision making is crucial, says Dr. Mack. Unfortunately, informed consent processes have been well described to be incomplete for many procedures, and my colleagues and I believed that OIT was no exception. With little research about preparing families for OIT, the study team sought to determine whether the use of adjunctive tools could help ensure the discussion of all major topics and challenges associated with OIT.

An OIT Educational Video & Checklist

For a study published in the Annals of Allergy, Asthma & Immunology, the researchers investigated the use of a counseling video and checklist aimed at improving parent and patient knowledge about OIT. During a 2-hour counseling session, families participating in the study performed a pre-test to gauge their knowledge about OIT and then watched a counseling video that addressed each of the questions in the test as well as many other aspects of OIT, followed by a post-test and a 1-hour, one-on-one counseling session with an allergist to review the key aspects of OIT and the test results. The checklist was used to ensure that all major topics and challenges were discussed with the family and to ensure that the shared decision-making process was complete.

The 35-minute counseling video was designed to present a balanced description of the OIT procedure and coveredthrough the use of statements, diagrams, images, and photographspractical elements, the current literature, risks, benefits, complications, alternatives, and key consent issues that were addressed in a written OIT information package provided to all participants in the initial consultation. The 21 questions in the pre- and post-tests highlighted key practical, safety, and efficacy issues about OIT. The long-term and noncurative nature of OIT, the severity of reactions, and the fact that OIT is not the current standard of care were addressed in eight questions predetermined to be high priority.

Improved Parent & Patient Knowledge

Using an adjunctive video and pre- and post-testing significantly improves parent, and even pediatric patient, knowledge of OIT, and a checklist can help clinicians ensure that the major aspects of OIT are full discussed with families before enrolling in this intensive procedure, says Dr. Mack. Prior to the educational video and counseling session, significant deficiencies in families knowledge and unrealistic expectations were observed in some participants, even among well-educated families. Although most questions deemed to be high priority for families to understand were answered correctly before the educational video, several were answered incorrectly in a significant number of participants. These incorrectly answered questions included the misconception that OIT is considered a cure for food allergy (it is not a cure) and the misconception that epinephrine use has not been used during OIT (it is used not infrequently), adds Dr. Mack.

In all patient groups, significant improvements were seen in mothers, fathers and patients knowledge of OIT. However, patients and fathers had a clearly lower baseline knowledge base than mothers (Figure). We strongly recommend that patients and both parents be actively included in all aspects of this counseling and consent process, Dr. Mack says. Thankfully, by implementing this approach, parent and patient knowledge improves, and satisfaction with this procedure was extremely high.

A counseling video with pre- and posttesting and checklist for oral immunotherapy consent improves participant knowledge https://www.annallergy.org/article/S1081-1206(20)30477-4/fulltext

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Improving Patient & Family Knowledge of Oral Immunotherapy - Physician's Weekly

Immunology

Evommune, Inc. Raises $12.5M in Seed Funding to Accelerate the Development of Transformative Medicines for Chronic Inflammatory Diseases – PRNewswire

LOS ALTOS, Calif., Nov. 18, 2020 /PRNewswire/ --Evommune, Inc., an innovation engine inchronic inflammation, announced the successful completion of a $12.5million seed financing by Pivotal bioVenture Partners. This financing will enable Evommune to build a pipeline of unique therapies for patients with chronic inflammatory diseases.

Approximately 60 percent of Americans live with chronic inflammatory diseases, and it is expected that the prevalence will increase steadily over the next 30 years.1 Evommune wants to improve the quality of life for patients living with these conditions. The company is using the skin as the lens to uncover new approaches for accelerating the development of vital medicines across immunology with a focus on inflammation and dermatology. By utilizing a novel screening platform, the company will identify molecules that are differentiated and have a greater probability of being effective in treating patients with chronic inflammatory conditions.

"There has been tremendous progress in the treatment of inflammatory diseases, but there are still many conditions that lack safe and effective therapies. This is where Evommune will make a difference," said Luis Pea, president and chief executive officer, Evommune, Inc. "This initial seed funding will be used to set up and drive the execution of our longer-term strategy. We have established both academic and industry collaborations and are building a pipeline that will include both discovery and clinical-stage development programs."

Evommune was co-founded by industry veterans Luis Pea, Eugene A. Bauer, MD, chief medical officer, and Hans Hofland, PhD, senior vice president, research. In addition to the founders Janice Drew, MPH joins the executive team as senior vice president, product development. All of the executives were former senior leaders at Dermira, Inc. which was subsequently sold to Eli Lilly and Company for approximately $1.1 billion in 2020. Together, the team is highly accomplished in global drug development and has an outstanding 30-year track record of rapid regulatory approvals and successful development of medicines across multiple therapeutic areas, including immunology and dermatology.

"We are always looking to invest in talented and passionate founders who are on a mission to develop new and innovative therapeutics," said Rob Hopfner, RPh, PhD, MBA, managing partner at Pivotal bioVenture Partners. "The Evommune team's years of immunology and dermatology experience gives them an edge in identifying and developing therapies that will improve the lives of patients with debilitating diseases."

Ash Khanna, PhD, MBA, venture partner at Pivotal bioVenture Partners noted, "There is a great need for new solutions to address chronic inflammation and we are delighted to partner with the stellar Evommune team for Pivotal's first seed-stage investment."

About Evommune, Inc. Evommune is a private, R&D company and innovation engine in chronicinflammation. Evommune is taking a tissue-based approach to advance insights and accelerate the development of transformative medicines in inflammatory diseases. Evommune was founded in 2020 by a successful and experienced leadership team focused on building a robust pipeline of unique therapies that help patients with chronic inflammatory diseases. The company is headquartered in Los Altos, California. For more information please visit Evommune.com.

About Pivotal bioVenture PartnersPivotal bioVenture Partners is a $300 million life sciences venture capital fund located in San Francisco, California. The fund invests in privately held companies developing innovative therapeutic products and platforms to address major unmet medical needs. Investments range from seed-stage deals to cross-over financings at all stages of the preclinical and clinical development spectrum.Pivotal's investment team brings diverse experience in venture capital, company building, and drug discovery and development to the table in working with entrepreneurs to advance their businesses. For more information please visit https://pivotalbiovp.com

1 Pahwa R, Goyal A, Bansal P, et al. Chronic Inflammation. [Updated 2020 Aug 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK493173/

Media Contact:Sheryl Seapy 949-903-4750[emailprotected]

SOURCE Evommune, Inc.

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Evommune, Inc. Raises $12.5M in Seed Funding to Accelerate the Development of Transformative Medicines for Chronic Inflammatory Diseases - PRNewswire

Immunology

University of Miami Health System Gastroenterologist Honored with Lifetime Disruptor Award – Newswise

Newswise Maria T. Abreu, M.D., a renowned gastroenterologist at the University of Miami Miller School of Medicine, was honored with the Lifetime Disruptor award at the American College of Gastroenterologys 2020 virtual meeting. Healio, an in-depth specialty clinical information service, presented the award, which was based on votes from her peers.

I am always challenging the accepted wisdom, said Dr. Abreu, who is professor of medicine and microbiology and immunology, and director of the University of Miami Health System Crohns & Colitis Center. There is always more to learn about a certain condition or treatment to see if we can do something more to help our patients.

A leader in basic science, translational research, clinical care and education, Dr. Abreu focuses her work on finding better treatments for inflammatory bowel disease (IBD) and other debilitating gastrointestinal conditions. She is also a leader in bringing the genetic and environmental factors of IBD development in the Hispanic population into research and clinical care.

In my laboratory work, I look for new approaches to improving patient care, such as reducing an inflammatory response from the immune system or providing a healthy diet to reduce IBD flare-ups, she said.

The Healio Lifetime Disruptor award, presented this year on Oct. 26, goes to a gastroenterologist or hepatologist who has consistently pushed the gastroenterology field forward through innovative treatments, practice management, patient care, or research. This year more than 1,000 readers and followers voted on eight awards for Healio Disruptive Innovators.

In 2019 Dr. Abreu received the Sherman prize awarded by The Bruce and Cynthia Sherman Charitable Foundation to recognize outstanding achievements in the fight to overcome Crohn's disease and ulcerative colitis. Taking care of patients and finding new ways to help them has been my lifes purpose, she said at the time. Thats what inspires my research the possibility of helping both my patients, as well as those that Ill never see.

Earlier this year, Dr. Abreu was honored with the Research Mentor Award by the American Gastroenterological Association(AGA) Institute CouncilsImmunology, Microbiology & Inflammatory Bowel Diseases Section. It is so important to be educating and mentoring young professionals and help them move ahead with their careers, Dr. Abreu said. They are the future of medicine.

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University of Miami Health System Gastroenterologist Honored with Lifetime Disruptor Award - Newswise

Immunology

Study reveals the metabolic signaling mechanisms that regulate function of eTreg cells – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Nov 17 2020

Effector regulatory T cells (eTreg cells) are a specialized subset of white blood cells that keep the immune system in check. St. Jude Children's Research Hospital scientists have revealed the metabolic signaling mechanisms that regulate function of eTreg cells. The work may aid efforts to better understand and treat inflammatory diseases. The findings were published online today in Cell Metabolism.

This process is quite fascinating to us, and helps explain how metabolites can drive selective signaling pathways to enforce the differentiation, persistence and function of eTreg cells. We were looking specifically at suppression of autoimmunity that can develop spontaneously in our models, but we also know Treg cells play a role in multiple diseases."

Hongbo Chi, Ph.D., Corresponding Author, St. Jude Immunology

Although eTreg cells are involved in prevention of autoimmune diseases, including lupus and rheumatoid arthritis, they are detrimental in other diseases, such as cancer. Understanding how metabolic signaling regulates Treg cell heterogeneity or function may help scientists develop more specific drugs to target these pathways to help treat disease. How metabolic pathways regulate the differentiation and persistence of eTreg cells, especially at the level of intracellular signaling, has been unclear until now.

The researchers showed that two-way metabolic signaling that intersects with T cell receptor signaling is critical to regulating eTreg cell function.

Investigators identified a class of metabolites called isoprenoids that are essential for the suppressive activity of activated Treg cells such as eTreg cells. Isoprenoids are required for cellular processes called posttranslational lipid modifications, specifically protein farnesylation and geranylgeranylation. These processes are mediated by Fntb and Pggt1b, respectively. Disruption of these processes by Treg cell-specific deletion of Fntb or Pggt1b causes mice to develop autoimmunity.

Further research into the metabolic signaling mechanisms revealed the discrete details of Treg cell-mediated immune suppression downstream of T cell receptor signaling. Fntb acts through two parallel pathways to promote eTreg cell persistence: the protein kinase mTORC1, which regulates metabolic reprogramming of Treg cells, and the immune receptor ICOS. Pggt1b enforces signaling through the small G protein Rac to support eTreg cell differentiation.

"We were able to dissect how metabolic regulation controls eTreg cell differentiation and maintenance," said first author and graduate student Wei Su of St. Jude Immunology. "This bidirectional interplay between intracellular signaling and metabolism allows eTreg cells to maintain the self-tolerance in our body."

"These pathways have been of long-standing interest outside of the immune system for a way to inhibit inflammatory responses," said study author Nicole Chapman, Ph.D., of St. Jude Immunology. "Our study provides a deeper understanding of the molecular interplay between signaling and metabolism and could allow for more potent and selective targeting of downstream metabolic functions in Treg cells."

Source:

Journal reference:

Su, W., et al. (2020) Protein Prenylation Drives Discrete Signaling Programs for the Differentiation and Maintenance of Effector Treg Cells. Cell Metabolism. doi.org/10.1016/j.cmet.2020.10.022.

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Immunology

Most Vaccines Can Be Give Safely, Even After Reactions – Medscape

For the majority of vaccine reactions, the vaccine can still be administered in graded doses, according to John Kelso, MD, from the UC San Diego School of Medicine.

John Kelso

"All anaphylactic reactions to vaccines should be evaluated in an attempt to determine the culprit allergen," but do not simply avoid giving the vaccine, he said during his presentation on the vaccine research frontlines at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.

It might be tempting to simply label the patient as "allergic to the vaccine," but that "may leave the patient inadequately immunized," he said.

It's best to investigate the allergy with available resources and following allergy investigation procedures, said Kelso.

If the patient has had a previous reaction to a vaccine and has a reaction immediately after receiving the vaccine, do a skin-prick test or an invitro lgE test of the vaccine and its components, Kelso recommended.

All ingredients in every vaccine are listed in the vaccine excipient summary appendix of the Pinkbook, which is published by the Centers for Disease Control and Prevention.

And an online compilation of excipients in vaccines per 0.5mL dose, from the John Hopkins Bloomberg School of Public Health, breaks down vaccines by component, and lists the excipients and allergens, alphabetically, including the amount per dose.

If the test is negative and additional doses of the vaccine are required, administer the vaccine as indicated. If the test is positive and additional doses of the vaccine are needed, they can be administered in graded doses.

The same procedure is recommended if a patient has a clinical history of allergy to gelatin, latex, or yeast, which are common ingredients in vaccines.

"Although there are possibilities of false positives, a 1to 100 dilution for the intradermal test has been shown to be nonirritating," Kelso reported. What's more, "it's important to note that there are no reports of patients who have had intradermal skin tests and have gone on to have a reaction."

If the patient has a reaction to the vaccine, but not immediately, usually no allergy workup needed. In almost all such cases, the vaccine can be administered, on the recommended schedule, in graded doses at 15minute intervals, under observation, he said. If a physician is reluctant to give additional doses, a lab test can be done to measure the patient's lgG antibodies to see if they are protected.

"Most influenza vaccines are literally grown in egg," Kelso said, and "they contain a residual amount of egg protein, or ovalbumin."

However, this has been thoroughly studied with injectable influenza vaccine and intranasal influenza vaccine, live and attenuated, and reactions are rare.

In 27 studies of inactivated vaccine administered to more than 4100 children, including those who have had anaphylactic reactions to egg, there were no reactions, he reported. And published reports describe 1129 children with egg allergy who received live attenuated intranasal flu vaccine, with no immediate systemic reactions.

"It turns out there's just not enough egg protein present to cause a reaction even in the most severely egg allergic patient," Kelso explained. The maximum amount of ovalbumin is less than 1g per 0.5mL dose of influenza vaccine, and amounts measured in independent laboratories are usually much lower than the amounts claimed.

"It is not necessary to inquire about egg allergy before the administration of any influenza vaccine, including on screening forms," according to the Recommendations for Prevention and Control of Influenza in Children, 20202021, issued recently by the American Academy of Pediatrics.

This is one of three main changes in vaccine administration that clinicians "may wish to make" in practice, Kelso said.

The second is that clinicians should be aware that Tdap, a vaccine for tetanus diphtheria and pertussis, can be given regardless of when a previous Tdvaccination was given. Limb swelling, which occurs in 2% to 3% of people after four or five doses, is not a contraindication to the vaccine, he explained.

And the third is that pregnant women can receive injectable (inactivated) influenza vaccine and Tdap, but not live vaccines.

Lisa Saiman

Social media focuses predominantly on negative experiences, which "are easier to perceive than the positive benefits of vaccination: the absence of disease," Lisa Saiman, MD, from the Columbia University Irving Medical Center in New York City, pointed out during her presentation.

The result is a cognitive bias against vaccination, "a disbelief of vaccine efficacy, and a mistrust in pharmaceutical companies and, of course, government," she said.

"But there is a spectrum of vaccine hesitancy and refusal," Saiman said. And there are several resources that physicians can use to explain the importance of vaccines to those who fall into the "cautious acceptor" and "fence sitter" categories, which will help providers maximize the number of patients they vaccinate.

Saiman recommends that providers use talking points from the Countering Vaccine Hesitancy clinical report to guide discussions with parents who are worried about vaccines.

Regular courses of immunization need to be followed, she emphasized. "During the COVID-19 pandemic, measles vaccination rates have declined," and we "clearly are at increased risk of future outbreaks."

"We need to provide catch-up vaccinations expeditiously, and pediatricians must communicate the effectiveness and safety of all vaccines," she stressed.

Kelso and Saiman have disclosed no relevant financial relationships.

American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting: Presented November3, 2020.

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Immunology

Analysis | Experts have doubts the first Covid-19 vaccines will bring herd immunity – News24

NEWS

Governments and officials are voicing hopes that Covid-19 coronavirus vaccines could bring herd immunity, with some calculating that immunising just two-thirds of a population could halt the pandemic and help protect whole communities or nations.

But the concept comes with caveats and big demands of what vaccines might be capable of preventing. Some experts say such expectations are misplaced.

For a start, figuring out whats needed to achieve herd immunity with Covid-19 vaccines involves a range of factors, several of which are unknown.

Read:Covid-19: No deal yet to access 90% effective vaccine tested in SA

What is the rate of the spread of the Covid-19-causing virus? Will the first vaccines deployed be able to stop transmission of the virus, or just stop people getting ill? How many people in a population will accept a vaccine? Will vaccines offer the same protection to everyone?

Herd immunity is sometimes wrongly understood as individual protection, said Josep Jansa, an expert in health emergency preparedness and response at the Stockholm-based European Centre for Disease Prevention and Control (ECDC).

Its inappropriate to think I will not be affected myself because there is herd immunity. Herd immunity refers to community protection, not to how an individual is protected.

The idea of herd community is to protect the vulnerable, said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

The ECDC uses an estimated herd immunity threshold of 67% for its models, while Chancellor Angela Merkel said this month that Covid-19 restrictions in Germany could be lifted if 60% to 70% of the population acquired immunity, either via a Covid-19 vaccine or through infection.

World Health Organisation experts have also pointed to a 65% to 70% vaccine coverage rate as a way to reach population immunity through vaccination.

The idea of herd community is to protect the vulnerable, said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

And the idea behind it is that if, say, 98% of a population have all been vaccinated, there will be so little virus in the community that the 2% will be protected. Thats the point of it.

REPRODUCTION RATE IS CRUCIAL

Central to the public health calculations on this concept for Covid-19 is the reproduction rate, or R value, of the virus that causes it.

This is a measure of how many other people an average infected person passes a pathogen on to in normal, or restriction-free, circumstances.

Assuming complete vaccine efficacy, herd immunity percentage thresholds for infectious diseases are calculated by dividing 1 by the R value, deducting the result from 1, and multiplying by 100.

Read:Herd immunity, second wave ... forget the jargon; this is what you need to know

For instance, herd immunity from highly contagious measles, with an estimated R value of 12 or higher, will kick in only if 92% or more within a group are immune. For a seasonal flu strain that could have an R value of 1.3, the threshold would be just 23%.

The problem is that for now we dont know exactly how fast the virus spreads without any precautions and with the normal travel and social activities we had a year ago, said Winfried Pickl, professor of immunology at the Medical University of Vienna.

With so many countries still operating in far from normal circumstances, the assumption should be that the Covid-19 R value would be closer to 4 than to 2, he said, since even with semi- or full lockdown measures the R value is around 1.5.

Additionally, anything less than 100% vaccine efficacy - such as the 90% or so suggested in early data on the Pfizer-BioNTech and Moderna Covid-19 shots - would require a matching rise in percentage of coverage to reach herd threshold.

Amesh Adalja, a scholar at the Johns Hopkins Center for Health Security, said a good target for immunity in the United States would be for more than 70% of the population to be inoculated, but added that the figure could go up if vaccines are less effective.

The idea of herd community is to protect the vulnerable,

Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh

STOP TRANSMISSION IN THE HERD?

Experts say another important factor is whether the Covid-19 vaccines a government chooses to deploy can stop transmission of the virus.

Evidence so far suggests the first Covid-19 vaccines to come to market will at least stop people developing the disease. But it cannot be ruled out that people will still catch the Covid-19 coronavirus and pass it on to others unnoticed.

The idea of herd community is to protect the vulnerable, said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh. said Penny Ward, a visiting professor in pharmaceutical medicine at Kings College London.

Bodo Plachter, a professor and deputy director of the Institute of Virology at Germanys Mainz University teaching hospital, said that respiratory infections in particular can be hard to block completely with vaccines - although the shots will go some way to reducing the amount of circulating virus.

It may well be that vaccinated people will shed fewer viruses, he said. But it would be a mistake to assume vaccination alone can suppress a pandemic.

Read:The party of Luthuli is imploding

FOCUS ON PROTECTING THE VULNERABLE?

Edinburghs Riley said this suggests that for now, pursuing an idea of herd immunity through Covid-19 vaccination is fruitless.

A better approach, she said, could be to turn herd immunity on its head, and use the first limited supplies of vaccines to protect those most in need, without worrying about the more robust members of the herd who can live relatively happily with the virus.

Lets forget about protecting the masses to protect the vulnerable, she said. Lets directly protect the vulnerable. Reuters

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Analysis | Experts have doubts the first Covid-19 vaccines will bring herd immunity - News24

Immunology

AAAAI-Supported Food Allergy Bill Passes the House of Representatives – Benzinga

MILWAUKEE, Nov. 17, 2020 /PRNewswire-PRWeb/ -- The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act (H.R. 2117), a bill supported by the AAAAI, passed the House of Representatives today with a unanimous voice vote. The FASTER Act directs the Centers for Disease Control and Prevention (CDC) to expand data collection of information related to food allergies and specific allergens, and revises the definition of major allergen to specifically include sesame. House Energy and Commerce Committee Chairman Frank Pallone (D-NJ), Ranking Member Greg Walden (R-OR), and Representative Doris Matsui (D-CA) spoke in support of the bill.

"The AAAAI joins with our Patient Advocacy Organization partners in celebrating the news that H.R. 2117 has successfully passed the House of Representatives," said AAAAI President Mary Beth Fasano, MD, MSPH, FAAAAI. "While it still needs to pass the Senate before it can be signed into law, this bill will do several things to improve the health and safety of Americans living with food allergies, including revising the definition of major allergens to include sesame, which is tremendously significant."

H.R. 2117 is sponsored by Representative Doris Matsui, who was joined by more than 90 bipartisan cosponsors. "Food allergies impact the daily lives of so many Americans, including our friends and family members," said Congresswoman Matsui. "Some of these food allergies can be serious and potentially be life-threatening diseases, and it's become abundantly clear to me that we need more research and evidence-based solutions to help understand, treat, and maybe one day prevent food allergies. I hope this legislation will provide progress treating allergies and improving the lives of those suffering from them."

The AAAAI continues to advocate for congressional adoption of H.R. 2117 which would advance recommendations from the National Academy of Medicine report "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy," including strengthening data collection on the prevalence of food allergies, and adding sesame to the list of allergens required to be listed on food labels, as well as providing flexibility for the Secretary of Health and Human Services to add any other food ingredients determined by regulation to be a major food allergen. The AAAAI joins its stakeholder partner FARE in support of this important legislation.

Passage of the FASTER Act comes after the Food and Drug Administration (FDA) recently issued a draft guidance titled "Voluntary Disclosure of Sesame as an Allergen". The document encourages food manufacturers to voluntarily declare sesame in the ingredient list on food labels. Comments on the draft guidance are due January 11, 2021. Additionally, the recently released Senate appropriations bill included a statement about allergen labeling expressing concern that the FDA has failed to take further action to require labeling for sesame and urging the agency to act swiftly to address this risk by requiring the same labeling for sesame as other major food allergens. Also included was report language requested by the AAAAI and other stakeholders which recognizes the prevalence of food allergy in the pediatric and adult communities, commends the ongoing work of the National Institute of Allergy and Infectious Diseases (NIAID) and the Consortium of Food Allergy Research (CoFAR), and encourages the NIAID to expand its clinical research network to add new centers of excellence in food allergy clinical care and to select such centers from those with a proven expertise in food allergy research.

AAAAI's professional governmental relations team and physician leadership continue to make a priority of encouraging federal research support for food allergies and related advocacy activities.

You can learn more about food allergies on the American Academy of Allergy, Asthma & Immunology website, aaaai.org.

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 7,100 members in the United States, Canada and 72 other countries. The AAAAI's Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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Media Contact

April Presnell, The American Academy of Allergy, Asthma & Immunology, 414-272-6071, apresnell@aaaai.org

SOURCE The American Academy of Allergy, Asthma & Immunology

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AAAAI-Supported Food Allergy Bill Passes the House of Representatives - Benzinga

Immunology

Analysis: Can first COVID-19 vaccines bring herd immunity? Experts have doubts – Reuters

FRANKFURT/LONDON (Reuters) - Governments and officials are voicing hopes that COVID-19 vaccines could bring herd immunity, with some calculating that immunising just two-thirds of a population could halt the pandemic disease and help protect whole communities or nations.

But the concept comes with caveats and big demands of what vaccines might be capable of preventing. Some experts say such expectations are misplaced.

For a start, figuring out whats needed to achieve herd immunity with COVID-19 vaccines involves a range of factors, several of which are unknown.

What is the rate of the spread of the COVID-19-causing virus? Will the first vaccines deployed be able to stop transmission of the virus, or just stop people getting ill? How many people in a population will accept a vaccine? Will vaccines offer the same protection to everyone?

Herd immunity is sometimes wrongly understood as individual protection, said Josep Jansa, an expert in health emergency preparedness and response at the Stockholm-based European Centre for Disease Prevention and Control (ECDC).

Its inappropriate to think I will not be affected myself because there is herd immunity. Herd immunity refers to community protection, not to how an individual is protected.

The ECDC uses an estimated herd immunity threshold of 67% for its models, while Chancellor Angela Merkel said this month that COVID-19 restrictions in Germany could be lifted if 60% to 70% of the population acquired immunity, either via a COVID-19 vaccine or through infection.

World Health Organization experts have also pointed to a 65%-70% vaccine coverage rate as a way to reach population immunity through vaccination.

The idea of herd community is to protect the vulnerable, said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh. And the idea behind it is that if, say, 98% of a population have all been vaccinated, there will be so little virus in the community that the 2% will be protected. Thats the point of it.

Central to the public health calculations on this concept for COVID-19 is the reproduction rate, or R value, of the virus that causes it. This is a measure of how many other people an average infected person passes a pathogen on to in normal, or restriction-free, circumstances.

Assuming complete vaccine efficacy, herd immunity percentage thresholds for infectious diseases are calculated by dividing 1 by the R value, deducting the result from 1, and multiplying by 100.

For instance, herd immunity from highly contagious measles, with an estimated R value of 12 or higher, will kick in only if 92% or more within a group are immune. For a seasonal flu strain that could have an R value of 1.3, the threshold would be just 23%.

The problem is that for now we dont know exactly how fast the virus spreads without any precautions and with the normal travel and social activities we had a year ago, said Winfried Pickl, professor of immunology at the Medical University of Vienna.

With so many countries still operating in far from normal circumstances, the assumption should be that the COVID-19 R value would be closer to 4 than to 2, he said, since even with semi- or full lockdown measures the R value is around 1.5.

Additionally, anything less than 100% vaccine efficacy - such as the 90% or so suggested in early data on the Pfizer-BioNTech and Moderna COVID-19 shots - would require a matching rise in percentage of coverage to reach herd threshold.

Amesh Adalja, a scholar at the Johns Hopkins Center for Health Security, said a good target for immunity in the United States would be for more than 70% of the population to be inoculated, but added that the figure could go up if vaccines are less effective.

STOP TRANSMISSION IN THE HERD?

Experts say another important factor is whether the COVID-19 vaccines a government chooses to deploy can stop transmission of the virus.

Evidence so far suggests the first COVID-19 vaccines to come to market will at least stop people developing the disease. But it cannot be ruled out that people will still catch the SARS-CoV-2 virus and pass it on to others unnoticed.

While protection against illness has a value for an individual, it will not prevent circulation of virus and risk of disease in unvaccinated (people), said Penny Ward, a visiting professor in pharmaceutical medicine at Kings College London.

Bodo Plachter, a professor and deputy director of the Institute of Virology at Germanys Mainz University teaching hospital, said that respiratory infections in particular can be hard to block completely with vaccines - although the shots will go some way to reducing the amount of circulating virus.

It may well be that vaccinated people will shed fewer viruses, he said. But it would be a mistake to assume vaccination alone can suppress a pandemic.

Edinburghs Riley said this suggests that for now, pursuing an idea of herd immunity through COVID-19 vaccination is fruitless.

A better approach, she said, could be to turn herd immunity on its head, and use the first limited supplies of vaccines to protect those most in need, without worrying about the more robust members of the herd who can live relatively happily with the virus.

Lets forget about protecting the masses to protect the vulnerable, she said. Lets directly protect the vulnerable.

Reporting by Kate Kelland in London and Ludwig Burger in Frankfurt, Additional reporting by Carl ODonnell in New York, Editing by Timothy Heritage

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Analysis: Can first COVID-19 vaccines bring herd immunity? Experts have doubts - Reuters